Ibrutinib regimens vs. chemoimmunotherapy in older patients with untreated CLL

Phase III testing sought to compare the effect of ibrutinib vs. chemotherapy in older patients with untreated chronic lymphocytic leukemia (CLL). Researchers recruited 547 Americans and Canadians aged 65 years and older for their sample population.

Phase III testing sought to compare the effect of ibrutinib vs. chemotherapy in older patients with untreated chronic lymphocytic leukemia (CLL). Researchers recruited 547 Americans and Canadians aged 65 years and older for their sample population. A total of 183 study participants were randomized to receive six cycles of standard chemoimmunotherapy with bendamustine plus rituximab. A group of 182 patients was assigned to daily ibrutinib alone, while a third treatment arm, also including 182 patients, received continuous ibrutinib plus rituximab. The primary outcome was progression-free survival, which came in at a rate of 74% after 2 years in the bendamustine group. For the ibrutinib patients, by comparison, the rate was 87% for monotherapy and 88% for the combination therapy, proving ibrutinib to be the superior approach. Ibrutinib therapy also produced a lower rate of hematologic adverse events rated at grades 3, 4, or 5 than bendamustine plus rituximab. Grade 3 and higher nonhematologic adverse events, however, were less likely with bendamustine plus rituximab than with ibrutinib. The secondary endpoint of overall survival, meanwhile, was comparable for all three treatment arms.